Recall Z-0355-2016— Procedure Products, Inc.
Class II · Terminated
Class II FDA medical device recall by Procedure Products, Inc., initiated 2015-10-27, terminated 2016-04-01. It names one FDA 510(k) clearance: K810859. Product: U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel. Vessel dilator, for percutaneous catheterization.. Reason: The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle.
- Recalling firm
- Procedure Products, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-27
- Terminated
- 2016-04-01
- Firm location
- Vancouver, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel. Vessel dilator, for percutaneous catheterization.
Reason for recall
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
Data sourced from openFDA. This site is unofficial and independent of the FDA.